While it may be true that some “current intervention practices de-incentive quality”, FDA regulations are intended to prevent harm to the device user, not to ensure quality. It is up to the discretion of the company to produce a product that Is not only safe and in compliance with regulation, but also one of good quality.

It is important to note that “Quality is defined as products and services that deliver intended performance, safety, and customer satisfaction, while compliance is defined as meeting regulatory requirements.” So even with regulation de-incentivizing quality, market competition should be sufficient motivation to make quality a priority along with compliance during device development.

I am however interested in what regulations de-incentivize quality and how.

http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDRH/CDRHReports/UCM277323.pdf

The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP's)
I found the types of CGMP Drug Inspections online.
• Surveillance Inspections
– Risk-based frequency
– Sites selected by risk model and local judgment
• For-Cause (Compliance) Inspections
– Local/HQ/Center initiated, e.g., f/u past violations
– External complaint/allegation
• Pre-Approval and Post-Approval Inspections
– Center established criteria (product-specific)
– Center or local office initiated for-cause

I believe that while FDA certifies devices and products for safety, the Quality of the device needs to just above the minimum requirement. Most competitive companies try to achieve much better quality to get the edge over others. No doubt certain times, regulatory bodies fall short in covering up loopholes while setting standards. When technologies improve and grow in a very short time, it must be well regulated by the regulatory bodies keeping the end users in mind. What I feel is, FDA regulations make the companies spend more money in testing the devices or products for safety and/or quality and hence, feel its an unfair practice or even the reason behind the failure to improve the quality of a product.

If a company strives to just make the standards of regulations, then it would follow that the product would not be of the best quality. Quality standards within many medical device companies however tend to surpass the standards of regulatory bodies for a variety of reasons. There is a marketing point to not only meeting regulatory standards but blowing past them: it can scream excellence for a device, making it more appealing to a customer. As mentioned above, quality can also sometimes be dictated by other competitors, rather than regulating bodies. Talking along the lines of excellence, when a company can guarantee a certain degree of quality it is a major selling point to have over a competitor. Therefore in order to beat that aspect of competition, quality standards can be driven by trying to beat the standards of competitors. Taking all of these things in mind, I don't think having government regulations is something that would really stifle quality of products. It may cause challenges in designing a product, but since quality can oftentimes be driven by factors other than regulatory bodies, I don't really see it causing a degradation in device quality.

FDA regulations tells the manufacturer that their product is complaint with regulations but does not offer any method to improve the quality of their product .The FDA increased scrutiny on inspection forced the industry to make changes that protect the end customer which causes an increase in price of product. everything we are focus on regulation compliance standpoint really inhibits us from truly driving after the quality improvement of our product. Medical Device Discovery Appraisal(MDDA) program helps the agency and medical device manufacturer to see quality assurance in new light. The program is designed to improve the quality of product with end goal of benefiting patients but also offers cost and efficiency benefits to manufacturer. FDA pushes quality over compliance, enhanced transparency, stakeholder engagement .It is important that everyone in the organization understands what the quality goal of the organization are so that they can properly align the procedure and principles that forms the overall quality policy for the company.

The FDA can unintentionally cause quality to be lowered through its regulations because companies may be forced to work around them. There may be loopholes associated with certain regulations and companies can use that to either raise prices for products and lower quality because of the legal liability. Many big companies(e.g. Johnson&Johnson) outsource their drug manufacturing facilities to other countries because they cannot afford to comply with US regulations on their product. Regulations are well-intentioned but they can have adverse consequences. If companies move to other countries that have less regulation, then there will be no point in the government implementing regulations as businesses will get away from such influences by outsourcing. Many FDA regulations cause artificial increases in drug prices. One such regulation would be that in order for a drug to get approved to the market, it has to be both safe and perform the desired affect on the patient. If the FDA allowed drugs that were safe but didn't work, then prices can fall dramatically. Even if quality is enhanced by the FDA regulations, the quality won't matter to customers if prices are too high.

I disagree with Dkonara921 on one aspect. I agree with the fact that regulations are made with good intentions, and that companies can work around them. I disagree with the notion that the FDA should allow drugs that don't work. Maybe you mean "drugs that don't work effectively, but still somewhat work". What's the point of marketing a drug that doesn't work? It's pointless. Why pay for a product, even a cheap product, that doesn't work? Quality matters, but pricing in accordance with quality could be a possibility for those who can't afford the best drugs but can get by on lower quality drugs.

While its true that regulations do not ensure quality, they are necessary for some level of standardization in the audit of products.Many times when companies try to stay at the top using innovative systems they can be affected by loopholes causing low-quality products to be out in the market and affecting peoples pocket. If drugs that did not work were out just to regularize prices like Dkonara921 mentioned above, then people would be wasting their money on useless products. It will also cause customers to not trust companies. Quality does matter, even if the price is high. If people have the money to buy high-end products they will do so because of the quality of it, not anything else. if people can't afford so, they would try harder to get it, because they trust it's quality.

@Zbw2 made an interesting point about market competition as a motivating factor for quality. A company wants to make sure their product is better than all the competitors, so they will be concerned with quality. While I think this is a valid point, what happens when there is no competition? What comes to mind is the case with epipen, they charged an absurd amount because they had a monopoly on the market. While this was not an issue of quality, it shows that an outside regulating agency is necessary and market competition is not sufficient.

I also think our economic market has unintentionally discouraged quality. There are constantly new phone upgrades and newer editions of products. It is somehow expected that the first edition will not be the best, but its okay as long as its "good enough". While improvement is important and newer editions of a product are not necessarily bad, when it comes to medical devices we want the first edition to be perfect because it will directly affect a persons life or health. Thus quality is at higher stakes.

An item in your posting has caught my attention: "Understanding Barriers To Medical Device Quality" This document has been extremely forthcoming as it regards the effort the Biomedical Engineer is making to improve medical devices with the intent to improve medical service rendered to patients by those in the medical arena. By the disclosure of this document this effort by the Biomedical Engineer has practically doubled the size of the medical device industry. This effort is not only focused on innovation, it is rendering medical devices ever more sophisticated. All of this with the intent to help eliminate diseases afflicting the human being.

Unfortunately, if one were to pit this increasing Biomedical Engineer's effort to the reciprocating efforts of the medical practitioner, the latter will be found to be practically non-existent. Instead, if statistics were to be examined, deaths from disease will be found to have doubled today compared to only a few years ago despite the more advanced tools the medical practitioner is being provided. The question is: "Why?"

The answer is simple, there is a huge difference in the intentions of the Physician and the Biomedical Engineer. The Biomedical Engineer's intents behind his efforts is rooted on the need to come with some creation that will help eliminate disease; exactly opposite to what the medical practitioner wants. The medical practitioner has no interest to eliminate disease. His makes no effort in wanting to know the actual cure of a given disease; hence, their continual reliance on pharmaceutical drugs which they know will not effect the cure of any disease. The medical practitioner's efforts are governed by greed.

So, irrespective of the innovations brought to medical device creation; or how much respect for quality standards may be applied to medical device creation, I have strong doubts regarding the elimination of disease.

The job of the FDA is "protecting the public health by assuring the safety, efficacy, and security of drugs, products, etc." Noticeably, this mission statement does not mention "quality." The term quality generally goes hand in hand with the duties of the FDA, but in reality, their responsibility is to ensure safety to consumers. The FDA for that reason does not replace the need for a company to have a rigid quality control system in place to oversee product development. The FDA could catch an issue in a device that is pre-market that causes it to overheat and cause a possible harm to consumers, requiring it to be fixed before this product can be commercially available. However, if the same problem offers no possibility to harm the consumer, but still causes the product to not operate to the level of effectiveness advertised, this could be detrimental to the company, and would be only at the fault of a poorly executed quality management branch of the company. For this reason, it is incredibly important to not simply rely on the FDA to ensure the quality of products, but to have a well managed and rigorous quality assurance branch performing tests, and being double checked for safety by the FDA.

It is important for both parties to keep in constant conversations. When a company finds a problem with a certain regulation they should try the best to report it to the FDA or ISO and to see if they can update the regulation. The FDA and ISO may not be on top of things when it comes to innovation and updating regulation when in comparison with companies. The main goal for a company and regulatory departments are to make sure that the products that are released to the public are safe and effective. Also, it is important that company to make sure they do their due diligence and make sure that their processes are actually better than what the government has put forward. When both parties effectively communicate and work together as a team rather than enemy can they actually help the general public. Also, within companies, it is important that they work together among departments to question each other works to improve the accuracy and decrease the risks.  

@Zbw2 brought up an intriguing argument regarding market competition encouraging quality. A firm will be concerned with quality if they want to ensure that their product is better than all of its rivals. While I believe this to be true, what happens when there is no competition?

It is critical that the firm conduct thorough due diligence and ensure that its practices are superior to those proposed by the government. Both parties can really assist the general public if they properly communicate and work together as a team rather than as adversaries. Also, inside organizations, it is critical that departments collaborate to challenge one another.